drugset / Trial / NCT00135499
R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.
Timeline
- Start
- 2001-10-16
- Primary completion
- 2010-04-27
- Completion
- 2010-04-27
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped (Enrollment): “Recruitment too low”
paper Correlation with event-free survival (EFS) and overall survival (OS) was performed in both cohorts PMID 27282998 ↗
Publications
- Background Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.
- Background Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
- Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.
- Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 10 mg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 1200 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 75 mg/m2 | — |
| Comparator | Prednisone | Other / unclassified | 40 mg | — |
| Comparator | Prednisone | Other / unclassified | 60 mg | — |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | — |
| Subject | Vindesine | Small molecule | 2 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |